The Potential Role of Sensory Testing, Skin Biopsy, and Functional Brain Imaging as Biomarkers in Chronic Pain Clinical Trials: IMMPACT Considerations

Shannon M. Smith, Robert H. Dworkin, Dennis C. Turk, Ralf Baron, Michael Polydefkis, Irene Tracey, David Borsook, Robert R. Edwards, Richard E. Harris, Tor D. Wager, Lars Arendt-Nielsen, Laurie B. Burke, Daniel B. Carr, Amy Chappell, John T. Farrar, Roy Freeman, Ian Gilron, Veeraindar Goli, Juergen Haeussler, Troels JensenNathaniel P. Katz, Jeffrey Kent, Ernest A. Kopecky, David A. Lee, William Maixner, John D. Markman, Justin C. McArthur, Michael P. McDermott, Lav Parvathenani, Srinivasa N. Raja, Bob A. Rappaport, Andrew S.C. Rice, Michael C. Rowbotham, Jeffrey K. Tobias, Ajay D. Wasan, James Witter

Research output: Contribution to journalReview articlepeer-review

47 Scopus citations


Valid and reliable biomarkers can play an important role in clinical trials as indicators of biological or pathogenic processes or as a signal of treatment response. Currently, there are no biomarkers for pain qualified by the U.S. Food and Drug Administration or the European Medicines Agency for use in clinical trials. This article summarizes an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials meeting in which 3 potential biomarkers were discussed for use in the development of analgesic treatments: 1) sensory testing, 2) skin punch biopsy, and 3) brain imaging. The empirical evidence supporting the use of these tests is described within the context of the 4 categories of biomarkers: 1) diagnostic, 2) prognostic, 3) predictive, and 4) pharmacodynamic. Although sensory testing, skin punch biopsy, and brain imaging are promising tools for pain in clinical trials, additional evidence is needed to further support and standardize these tests for use as biomarkers in pain clinical trials. Perspective The applicability of sensory testing, skin biopsy, and brain imaging as diagnostic, prognostic, predictive, and pharmacodynamic biomarkers for use in analgesic treatment trials is considered. Evidence in support of their use and outlining problems is presented, as well as a call for further standardization and demonstrations of validity and reliability.

Original languageEnglish (US)
Pages (from-to)757-777
Number of pages21
JournalJournal of Pain
Issue number7
StatePublished - Jul 2017


  • Biomarkers
  • brain imaging
  • sensory testing
  • skin punch biopsy

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Anesthesiology and Pain Medicine


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